Emgality Side Effects
Emgality (galcanezumab) is generally well-tolerated with injection site reactions being the most common side effect, but serious adverse events including allergic reactions, hypertension, and Raynaud's phenomenon require monitoring. 1
Most Common Side Effects
- Injection site reactions are the most frequently reported adverse effect with Emgality 1
- Upper respiratory tract infections, nasopharyngitis, and influenza are commonly reported but generally mild 2, 3
- In clinical trials with 2586 migraine patients, the adverse event profile was similar to placebo, with most events being mild 1
Serious Adverse Events Requiring Immediate Attention
Allergic Reactions
- Hypersensitivity reactions including itching, rash, hives, dyspnea, and trouble breathing can occur days after injection 1
- Anaphylaxis and angioedema have been reported in postmarketing surveillance 1
- One case report documented a systemic allergic reaction requiring emergency intervention with IV steroids and antihistamines in a patient with underlying mast cell disorder and autoimmune conditions 4
- Seek emergency medical help immediately if you develop swelling of the face, mouth, tongue, throat, or difficulty breathing 1
Hypertension
- Development of new-onset hypertension or worsening of pre-existing hypertension can occur, most frequently within 7 days of therapy initiation 1
- Some cases have required hospitalization and initiation of antihypertensive medications 1
- Real-world data shows 23.3% of patients may develop worsening blood pressure after starting erenumab (a related CGRP monoclonal antibody), with one patient experiencing non-ST elevation myocardial infarction attributed to hypertensive emergency 5
- Monitor blood pressure regularly, especially in the first week after starting treatment 1
- Patients with atrial fibrillation appear at higher risk for blood pressure elevation 5
Raynaud's Phenomenon
- Fingers or toes may become numb, cool, painful, or change color from pale to blue to red 1
- Symptoms typically occur after a median of 71 days following dosing with CGRP monoclonal antibodies 1
- Many cases have resulted in serious outcomes including hospitalization and disability related to debilitating pain 1
- Discontinue Emgality if signs or symptoms of Raynaud's phenomenon develop 1
- Patients with pre-existing Raynaud's should be monitored closely for worsening or recurrence 1
Long-Term Safety Profile
- In a 5-year open-label study of erenumab (a related CGRP monoclonal antibody), no new safety signals emerged with prolonged exposure 2
- Exposure-adjusted adverse event rates were 123.0 per 100 patient-years, with serious adverse events occurring at 3.8 per 100 patient-years 2
- Real-world data through 24 months showed adverse events in only 12.6% of patients, all mild in severity 6
Important Clinical Considerations
Contraindications
- Do not use Emgality if you have serious hypersensitivity to galcanezumab or any excipients 1
Special Populations
- Safety in pregnancy is unknown; a pregnancy registry exists (1-833-464-4724) 1
- Unknown if Emgality passes into breast milk 1
- In pediatric patients (ages 6-17), the safety profile appears consistent with adults, with upper respiratory tract infection, headache, and vomiting being most common 7
Monitoring Recommendations
- Check blood pressure before starting treatment and monitor regularly, especially within the first week 1
- Assess for cardiovascular risk factors in patients over 40 years before initiating therapy 8
- Monitor for signs of Raynaud's phenomenon, particularly in patients with pre-existing vascular conditions 1
- Watch for delayed hypersensitivity reactions that can occur days after administration 1
Rare but Serious Events from Related CGRP Antibodies
While these events are from erenumab (another CGRP monoclonal antibody), they warrant awareness:
- Myocardial infarction has been reported, including cases without coronary abnormalities on angiography 8
- One case of status epilepticus and progressive brain injury occurred in a patient with cerebral proliferative angiopathy and compromised blood-brain barrier 9
- Avoid CGRP monoclonal antibodies in patients with intracranial vascular malformations or compromised blood-brain barrier 9